CRP 104 Lecture 3 PROTOCOL

Question 1

purpose of protocol

Answer 1

tells use who, what. where, why, when and how
-protects participants
-protects study integrity
-allows documented changed to CT

Question 2

protocol definition

Answer 2

document descirbes objectives, design, methdology, statistical analysis and organization of CT

Question 3

why protocols are important

Answer 3

-affects all aspects of the trial conduction, data collection and quality.
-affects other documents such as ICF, CRF, regulatory submissions, package-inserts for consumers, etc

Question 4

study hypothesis

Answer 4

proposes possible explanation to an event or phenomenon. Must be testable by the CT

Question 5

protocol title

Answer 5

needs to be detailed, contains information on the population, IP, design, dosage, objectives

Question 6

protocol title page

Answer 6

reguatory registration number, study identification number, version and date, amendements, drug name, study phase, indication, popuation, authors, PIs, advisors, sponsor, CRO, conact info for all responsibile people, confidentiality statement

Question 7

after the title page

Answer 7

singature page of authors and responsible personnel, list of abrreviations.

Question 8

protocol synopsis

Answer 8

key methods, outcome variables, contains no new info that cannot be found in protocol

Question 9

background/intro of protocol contains (8)

Answer 9

-name and decription of IP
-nonclinical and clinical study findings
-known and potential risks and benefits
-decription and justification of administration route, dose, regime, treatment period
-GCP compliance statement
-CONSORT statement (justification for the clinical trial) - CT answers questions that cannot be answered by existing literature
-

Question 10

protocol methods and procedures contains (3)

Answer 10

-study design, pop, intervention, sample selection, analysis
-explain inclusion of drug, device or treatment in treatement plan
-tests and procedure, study events, study visits for all staff, IRB, and participants, high level schedule of events/timeline

Question 11

subject withdrawal criteria/stopping rules

Answer 11

-when and how to withdraw participants (prevent bias)
-type and timing of data to be collected from withdrawn participants
-whether and how to replace partcicpants
-follow up for withdrawn participants

Question 12

subject selection/inclusion criteria

Answer 12

-characteristics of pop
-age
-health
-number of subjects
-gender and race balances
-methods for screening and determining eligibility descirbed in detail (medical history, physcial exam, blood tests, etc)
-must explain exclusion of certain genders, races or other minorities
-must meet all inclusion criteria and no exclusion criteria

Question 13

exclusion criteria

Answer 13

-patients will not benefit
-inability to give informed consent
-intervention harmful
-comorbidities and cocontaminant medication

Question 14

protocol safety/confidentiality, data storage

Answer 14

-reporting of AEs, SAEs
-how will data be stored and confidential

Question 15

Potential risks and benefits

Answer 15

explanation of risks and benefits, risks must be reasonable in comparison to benefits
-how will risks be minimized

Question 16

monitoring and management

Answer 16

-data safety monitoring comittee
-AE reporting
-rescue therapy
-stopping guidelines